NATCO Pharma Limited Kothur Village, Mahaboob Nagar District
Form 483 issued October 18, 2023 · Rangareddy, India
- Inspection
- Oct 9 – Oct 18, 2023
- Investigators
- Pratik S. Upadhyay· Saleem A. Akhtar
- Observations
- 8
- Pages
- 27
- FEI number
- 3004540906
In short: On October 18, 2023, FDA issued a Form 483 with 8 observations to NATCO Pharma Limited Kothur Village, Mahaboob Nagar District in Rangareddy, Telangana (FEI 3004540906) after an inspection that ran Oct 9 – Oct 18, 2023. The investigators were Pratik S. Upadhyay and Saleem A. Akhtar. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Facilities & equipment and production account for 6 of 8 observations.
Most cited: 21 CFR 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmNATCO Pharma Limited Kothur Village, Mahaboob Nagar District history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?
Pratik S. Upadhyay and Saleem A. Akhtar are named on this Form 483, for the inspection of Oct 9 – Oct 18, 2023. Each investigator has a profile showing what they cite most.
When was NATCO Pharma Limited Kothur Village, Mahaboob Nagar District inspected by FDA?
The inspection ran Oct 9 – Oct 18, 2023, and the Form 483 is dated October 18, 2023.
How do I get the full Form 483 for NATCO Pharma Limited Kothur Village, Mahaboob Nagar District?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.